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Procedure

Digital Tomosynthesis vs. Standard Mammography for Breast Cancer Screening

Phase 3
Recruiting
Led By Etta Pisano
Research Sponsored by ECOG-ACRIN Cancer Research Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women of childbearing potential must not be known to be pregnant or lactating
Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4.5 years after last registration
Awards & highlights
Pivotal Trial
No Placebo-Only Group

Summary

This trial looks at two ways of screening for breast cancer, and whether one is better than the other.

Who is the study for?
This trial is for women who are not pregnant or breastfeeding, have not had a mammogram in the last 11 months, and show no symptoms of breast disease. Women with dense breasts or postmenopausal women on hormone therapy or with family history/genetic risk for breast cancer may be eligible. Those with prior breast cancer or enhancements are excluded.
What is being tested?
The study compares digital tomosynthesis mammography (3D imaging) and standard digital mammography (2D imaging) to see which is more effective for breast cancer screening and reducing unnecessary follow-up procedures.
What are the potential side effects?
Mammography generally has minimal side effects; however, discomfort during the procedure can occur. There's also exposure to low-dose radiation, which carries a very small risk of potentially contributing to future cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not pregnant or breastfeeding.
Select...
I have never had breast cancer or ductal carcinoma in situ before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4.5 years after last registration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4.5 years after last registration for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Proportion of women diagnosed with an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of follow up after the last screen
Secondary study objectives
Biopsy
Assess the predictive performance of tomosynthesis mammography (TM) and digital mammography (DM)
Biopsy rates
+14 more

Side effects data

From 2019 Phase 2 trial • 77 Patients • NCT01251575
5%
Hypoxia
5%
Febrile neutropenia
5%
Acute kidney injury
4%
Blood bilirubin increased
4%
Diarrhea
4%
Creatinine increased
4%
Sepsis
3%
Hypotension
3%
Left ventricular systolic dysfunction
3%
Bronchopulmonary hemorrhage
3%
Chronic kidney disease
3%
Thromboembolic event
3%
Lung infection
1%
Atrial fibrillation
1%
Atrial flutter
1%
Hemolysis
1%
Hemolytic uremic syndrome
1%
Ejection fraction decreased
1%
Encephalitis infection
1%
Gastric hemorrhage
1%
Gastritis
1%
Heart failure
1%
Mucositis oral
1%
Multi-organ failure
1%
Myalgia
1%
Pleural effusion
1%
Respiratory failure
1%
Small intestine infection
1%
Syncope
1%
Treatment related secondary malignancy
1%
Typhlitis
1%
Fever
1%
Paroxysmal atrial tachycardia
1%
Ascites
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Fludarabine, Transplant, Immunosuppression)

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm B (digital tomosynthesis mammography)Experimental Treatment2 Interventions
Patients undergo manufacturer-defined screening TM at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
Group II: Arm A (digital mammography)Experimental Treatment2 Interventions
Patients undergo bilateral screening DM with standard CC and MLO views at baseline, 12, 24, 36, and 48 months if pre-menopausal or at baseline, 24, and 48 months if post-menopausal.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Digital Tomosynthesis Mammography
2017
N/A
~3160

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,956 Previous Clinical Trials
40,983,188 Total Patients Enrolled
Canadian Cancer Trials Group (CCTG)UNKNOWN
1 Previous Clinical Trials
325 Total Patients Enrolled
ECOG-ACRIN Cancer Research GroupLead Sponsor
121 Previous Clinical Trials
51,292 Total Patients Enrolled
Etta PisanoPrincipal InvestigatorECOG-ACRIN Cancer Research Group

Media Library

Digital Mammography (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03233191 — Phase 3
Mammogram Research Study Groups: Arm B (digital tomosynthesis mammography), Arm A (digital mammography)
Mammogram Clinical Trial 2023: Digital Mammography Highlights & Side Effects. Trial Name: NCT03233191 — Phase 3
Digital Mammography (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03233191 — Phase 3
Mammogram Patient Testimony for trial: Trial Name: NCT03233191 — Phase 3
~58372 spots leftby Dec 2030